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Why is GCP important?

GCP compliance provides public assurance that the rights, safety and well-being of
human subjects involved in research are protected

What are the goals of GCP?
1. To protect the rights, safety and welfare of humans participating in research
2. To assure the quality, reliability and integrity of data collected
3. To provide standards and guidelines for the conduct of clinical research
4. Good Clinical Practice = Ethics + Quality Data

What are the foundations for the ethical conduct of clinical research?
1. The Nuremberg Code (1947)
2. The Declaration of Helsinki (1964)
3. The Belmont Report (1979)
4. International Conference on Harmonisation (ICH-GCP)
5. International Standards Organization 14155
6. Code of Federal Regulations

Nuremberg Code (1947)
- Voluntary participation
- Informed Consent
- Minimization of risk

Declaration of Helsinki (1964)
- Well-being of subject takes precedence
- Respect for persons
- Protection of subjects health and rights
- Special protection for vulnerable populations

Belmont Report Ethical Principles (1979)
- Respect for Persons
• Informed consent
• Protection of vulnerable populations
- Beneficence
• Non-malfeasance
- Justice
• Fairness

The International Conference on Harmonisation (ICH-GCP)
GCP is an international quality standard that is provided by the International
Conference on Harmonisation (ICH)
Goals: Harmonize technical procedures and standards; improve quality; speed time
to market
In 1997, the FDA endorsed the GCP Guidelines developed by ICH
ICH guidelines have been adopted into law in several countries, but used as
guidance for the FDA in the form of GCP

Each individual is qualified (education.What are the 13 principles of ICH-GCP? Ethics: 1. scientific & operational for designing. Nonclinical and clinical information supports the trial 5. Benefits justify risks 3. Freely given from every subject prior to participation Data quality and integrity: 10. IRB/IEC approval prior to initiation 7. Compliance with a scientifically sound. Accurate reporting.g. safety.g. experience) to perform his/her tasks Informed Consent: 9. Protects confidentiality of records Investigational Products 12. Systems with procedures to ensure quality of every aspect of the trial Compare Helsinki and ICG-GCP DECLARATION OF HELSINKI: • Ethical principles e. and well-being of subjects prevail Protocol and science: 4. Medical care/decisions by qualified physician 8. Conform to GMP's and used per protocol Quality Control/Quality Assurance 13. interpretation. detailed protocol Responsibilities: 6. Ethical conduct of clinical trials 2. conducting. Rights.International medical societies • Guidance with broad recommendations ICH-GCP: • Broader principles e. ethical and scientific • Focus: Physicians in research • World Medical Assembly . ethical. reporting & recording trials • Focus: Drug sponsors. investigators & IRB • Representatives from industry and public health • Guidance document but has the effect of law ?when put into Regulation What is the International Standards Organization? ISO 14155: Clinical Investigation of Medical Devices for Human Subjects . training. and verification 11.

Adverse Device Effect Reporting [Adverse Event (AE) or Serious Adverse Event (SAE)] .Electronic Records & Signatures 21 CFR 50 .Financial Disclosure 21 CFR 56 . and clinical investigators in the design and conduct of device clinical investigations .IRB-approved protocol .Valid data collection/reporting procedures Who is responsible for GCP compliance? -Sponsors -Clinical Investigators (CIs) -Independent Ethics Committees (IECs) .Premarket Approval of Medical Devices ..Proper documentation .Protection of Human Subjects 21 CFR 54 .Monitoring Plan .Assists regulatory bodies and ethics committees in their roles of reviewing clinical investigational plans What constitutes Good Clinical Practice in device research? .Assists sponsors.(IRBs) -Contract Research Organizations (CROs) -Research nurses -Clinical Research Coordinators (CRCs) -Clinical Research Associates (CRAs) -Medical monitors -Data entry personnel -Others How does FDA implement GCP? 21 CFR 11 .Valid Informed Consent .Investigational Device Exemptions 21 CFR 814 . monitors.Institutional Review Boards 21 CFR 812 .